A Helping Hand Among Low-Income Patients (AHH)

A Helping Hand (AHH) to Activate Patient-Centered Depression Care Among Low-Income Patients

Study Hypotheses (Ho) and Research Questions (RQ):

• Ho1. AHH will significantly improve patient depression treatment acceptance/adherence and depression symptoms vs UC at 6 and 12 months post-baseline.
• Ho2. A Helping Hand (AHH) will significantly improve and sustain patient self-care management in Self-Efficacy for Managing Chronic Disease (SEMCD) and Quality of Life vs UC at 6 and 12 months post-baseline.
• RQ1. What is the association between depression symptoms and concurrent chronic illness self-care management over time by group?
• RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic appointment-keeping?
• RQ3. Will patient care satisfaction and reported barriers to self-care management vary by study group?
• RQ4. What factors are identified via qualitative assessments of patients, promotoras, Department of Health Services (DHS) medical and social work providers, and DHS clinic/organizational leadership regarding satisfaction with, sustainable uptake of, and suggested modifications of the AHH promotora delivery model?
• RQ5. What potential technology applications would enhance promotoras delivering patient-centered self-care training and resource navigation, communicating and integrating care with DHS, and disseminating AHH?

Study Overview

• Status: Completed
• Conditions: Depression; Diabetes; Heart Disease
• Intervention / Treatment: Behavioral: Self-care management

Detailed Description

Major depression, plus other chronic illness such as diabetes, coronary heart disease and heart failure is common among low-income, culturally diverse safety net care patients. Unfortunately, many of these patients are uncomfortable about either asking their doctor questions about their illness and treatment options and their illness self-care or informing their doctors about their treatment preferences. Lack of strong engagement with medical providers occurs because patients believe they lack the knowledge to ask questions or to understand and follow recommended self-care and their concern that their medical provider lacks understanding of their treatment preferences. These factors often result in patient worry, poor adherence to prescribed treatment, and worsening illness status and even early death. The study will be conducted by a university, the Los Angeles County Department of Health Services (DHS) and a community health worker organization research team. The study will be conducted within two DHS Patient-Centered Medical Home clinics, with each patient having a designated primary care team of physician, nurse, social worker and medical assistant. Study patients with major depression and other illnesses face numerous self-care management barriers: managing concurrent symptoms (depression, pain, anxiety etc.) and cultural influences (depression stigma, diet), difficulty in navigating primary and specialty doctor and treatment plans, while at the same time experiencing daily social and economic stress. The randomized comparative effectiveness study plans to recruit 350 patients with major depression and a concurrent chronic illness (i.e., diabetes, heart failure, coronary heart disease) from two DHS PCMH community health centers. To enhance patient-centered research community partnerships, patients will be provided A Helping Hand (AHH) in which a community organization- based promotora aims to activate patient-centered depression self-care training and practical assistance to: a) improve and personalize major depression self-care (e.g., medication or psychotherapy preference, treatment adherence, fatigue, pain, diet, activity, stress management, family/caregiver communication); b) activate patient-provider communication, clinic appointment keeping and treatment coordination; and c) and facilitate patient navigation and receipt of needed community resources. AHH aims to improve patient self-care management and patient-provider care management relationships among underserved low-income patients, who must simultaneously cope with major depression and chronic co-morbid physical illness. Study objectives aim to determine: 1) whether community health worker promotora care management training improves patient-centered outcomes, such as self-care need and management, treatment adherence, symptom improvement, and care satisfaction over the usual team care; 2) depression symptom improvement; and 3) patient hospitalizations and ER visits frequency.

• Study Type: Interventional
• Enrollment (Actual): 348
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • El Monte, California, United States, 91731
      • El Monte Comprehensive Health Center
    • Los Angeles, California, United States, 90007
      • H. Claude Hudson Comprehensive Health Center
    • Los Angeles, California, United States, 90022
      • Edward R. Roybal Comprehensive Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age >=18 years, have a phone, meet PHQ-9 score of 10 or more, and have concurrent diabetes, CHD, or HF.

Exclusion Criteria:

• current suicidal ideation,inability to speak either English or Spanish fluently, a score of 2 or greater on the CAGE 4M alcohol assessment,recent use of lithium or antipsychotic medication, and cognitive impairment precluding informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A Helping Hand (AHH); Participants receive DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.	Behavioral: Self-care management; AHH behavioral intervention is provided by promotoras
NO_INTERVENTION: Usual Care (UC); Participants receive DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline	The PHQ-9, which establishes provisional depressive disorder diagnosis as well as grades depressive symptom severity, will be obtained from all study subjects at recruitment and during the four waves of data collection (up to 12 months). The PHQ-9 scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), with possible scores ranging from 0 to 27, with cut points of 5,10,15, and 20 representing the thresholds for mild, moderate, moderately severe, and severe depression. A validated Spanish version of the PHQ-9 will be used. Clinically meaningful improvement of depressive symptoms was assessed as a ≥50% score reduction since baseline assessment.	6- and12-month follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)	The Physical Component Summary (PCS) is a norm-based score standardized to the general U.S. population with a mean of 50, and a SD of 10. Scores range from 0 to 100, a higher score indicating better physical health.	baseline, 6- and 12-month follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score	The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.	baseline, 6- and 12-month follow-ups

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Kathleen Ell, DSW, USC Suzanne Dworak-Peck School of Social Work

Publications and helpful links

General Publications

• Oh H, Ell K. Associations Between Changes in Depressive Symptoms and Social Support and Diabetes Management Among Low-Income, Predominantly Hispanic Patients in Patient-Centered Care. Diabetes Care. 2018 Jun;41(6):1149-1156. doi: 10.2337/dc17-2000. Epub 2018 Mar 27.
• Ell K, Aranda MP, Wu S, Oh H, Lee PJ, Guterman J. Promotora assisted depression and self-care management among predominantly Latinos with concurrent chronic illness: Safety net care system clinical trial results. Contemp Clin Trials. 2017 Oct;61:1-9. doi: 10.1016/j.cct.2017.07.001. Epub 2017 Jul 3.
• Ell K, Aranda MP, Wu S, Oh H, Lee PJ, Guterman J. Promotora assisted depression care among predominately Hispanic patients with concurrent chronic illness: Public care system clinical trial design. Contemp Clin Trials. 2016 Jan;46:39-47. doi: 10.1016/j.cct.2015.11.012. Epub 2015 Nov 17.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (ESTIMATE): May 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: depression; community health worker; promotoras; self-care behaviors activation; low-income patients; safety-net care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Mood Disorders; Heart Diseases; Depression; Depressive Disorder
• Other Study ID Numbers: AD-1304-7364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO